INTEGRATED BIOMEDICAL TECHNOLOGY RESEARCH RESOURCES FOR PROTEOMICS AND
GLYCOMICS
RELEASE DATE: July 22, 2002
PA NUMBER: PA-02-132
EXPIRATION DATE: November 1, 2003, unless reissued.
National Center for Research Resources (NCRR)
(http://www.ncrr.nih.gov)
Letter of intent receipt dates: January 1, May 1, September 1
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Center for Research Resources proposes to foster the development
of improved technologies and methods for proteomics and glycomics research by
sponsoring integrated Biomedical Technology Research Resources through the
P41 mechanism. One way to confront the growing analytical challenges of the
genome era is to pursue technology development primarily along integrated
lines of inquiry rather than single technologies. This is particularly true
in the field of proteomics. These integrated Research Resources will develop
a range of innovative analytical tools and methods, and apply these tools to
biologically significant problems. The Research Resources will also provide
broad access to these integrated technologies through collaboration, service,
training, and dissemination activities.
While some responses to this program announcement will concentrate on core
proteomics technologies, those with special expertise in analytical
glycobiology are encouraged. The multiple roles of glycosylation in the
structures, trafficking, and activities of proteins present a complex
analytical challenge which is important to address as a component of efforts
to unravel the proteome. The post-translational nature of this modification
necessitates both a difference of approach and a range of specific
technological and bioinformatics tools that can be integrated into the
broader context of proteomics experiments.
RESEARCH OBJECTIVES
The Division of Biomedical Technology (DBT) of the National Center for
Research Resources (NCRR) supports Biomedical Technology Research Resources
through the P41 grant mechanism. Scientists at these centers conduct
research to create and disseminate innovative technologies and methods
applicable to a broad spectrum of biomedical research problems. The
increasing complexity of the biomedical research enterprise adds urgency to
the need for continued development of more fully integrated analytical
technologies, deriving their focus from a line of inquiry. Proteomics is a
field in which this need is both significant and easily demonstrated.
It is anticipated that these integrated centers may be significantly larger
and more complex than a more narrowly defined research resource. These
centers may be expected to draw together the expertise of experienced
investigators whose areas of specialization and established research focus
will contribute to the overall goals of the project. It is not absolutely
required that all participating investigators and laboratories be collocated
either at a single institution or in the same local geographic area.
However, because of the need for integration of technologies at a fundamental
level, it is considered critical that participating investigators be in a
position to work closely together in an iterative manner. This is seen as
particularly important for example in the effective interfacing of analytical
instrumentation. These issues should be addressed in detail in the
application. The project will be administered through the principal
investigator and his/her institution.
Proposed integrated research resource centers should focus on the core
technological and methodological problems of proteomics. Regardless of the
specific experimental approaches taken in proteomics experiments, a common
theme in this field is the need for synergy among three principal domains:
(1) biological competencies, (2) analytical chemistry, and (3) computational
tools. These domains should each inform the development of tools and methods
in their counterpart areas. Accomplishing this goal in a climate of
specialization demands a fundamentally collaborative approach. Within the
broad scope of proteomics, there are perhaps five types of questions that are
addressed in some form: (1) identification of individual proteins, (2)
recognition of protein interactions, (3) relative quantitation to distinguish
differential expression of proteins, (4) characterization of post-
translational modifications, and (5) formulation of models based on results
from components 1-4.
These issues are deliberately discussed with respect to fundamental
analytical challenges, rather than in relation to specific technologies, in
order to emphasize the overriding importance of surmounting these obstacles,
irrespective of the analytical strategy adopted to pursue those solutions.
This solicitation is open to unconventional or alternative approaches.
Development of complex, integrated approaches to proteomics problems will
require a context within which methods development can proceed.
Investigators may wish to select a model system or define a biological
research topic that will serve as a framework for the technological research
and development activities of the resource. Similarly, the challenges
broadly stated above may be too broad for a single resource to address
comprehensively. Investigators will be expected to clearly define the scope
of their activities, and this definition should inform their choice of
biological context, if any.
Integrated research resources in proteomics will eventually be expected to
have a broad-based, significant impact on a variety of biological problems,
both through collaborative projects and those initiated within the resource.
However, ultimately, the most important deliverables will be state-of-the-art
technology and methods for proteomics research.
Post-translational modification is a point of concern in the development of
strategies for proteomics. Because these modifications cannot be inferred
directly from gene sequence, they generally can only be characterized
directly. This raises issues about sequence coverage and stoichiometry of
modifications that are not presented by proteomics problems focused on
protein identification. In particular, the complexity and diversity of
glycosylation events significantly complicates the linkage between genetic
sequence and mature, active proteins. Because glycosylation is mediated by a
wide range of factors, discovery-based analytical tools that can survey the
complexities of glycosylation on a system-wide basis may have significant
biological impact.
Apart from the obstacles presented by proteomics in the general case,
glycobiology-focused proteomics, or glycomics, requires the development of
novel approaches and tools directed at the special challenges of
glycobiology. Strategies for separation, profiling, quantitation, and
detailed characterization of carbohydrate structures are central challenges.
Bioinformatics tools are needed for data handling and reduction, correlation
of carbohydrate and protein information, recognizing shifts in glycoprotein
microheterogeneity, and model building. Synthesis, three-dimensional
structural analysis, and a variety of other carbohydrate-specific analytical
tools may prove necessary to varying degrees, depending on the global
strategies adopted and thematic focus of a center.
Ultimately, laboratories engaged in glycomics will need the tools of
mainstream proteomics, and these additional specialized capabilities as well.
Because of the breadth of challenges inherent in developing effective tools
in both proteomics and glycomics, we wish to encourage laboratories with
special expertise in analytical glycobiology to address those technological
problems that are inherent in and unique to glycomics.
MECHANISM(S) OF SUPPORT
This PA will use the NIH P41 award mechanism. Existing NCRR P41 research
resource centers may apply through submission of an application for a
competitive supplement. An application for a competing supplement cannot
have a project period that extends beyond the current P41 grant period. It
is anticipated that a supplemental award would result in an expansion of the
scope of the main grant at the next competitive renewal. As an applicant,
you will be solely responsible for planning, directing, and executing the
proposed project.
Applicants may request a project period of up to five years. These awards
may be renewed by submission of competing-continuation applications. Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of NCRR provide support for this
program, awards pursuant to this PA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
The NCRR Division of Biomedical Technology places a ceiling on Biomedical
Technology Resource Center applications of $700,000 in direct costs
(excluding equipment) per budget period and/or $500,000 total in equipment
for the duration of the requested award. Applications exceeding these
ceilings require a written waiver from the Division Director. The waiver
must be requested well in advance of submission of the application, and must
be included in the application, along with the scientific rationale for
exceeding the ceiling. It is understood and expected that integrated
research resource centers will very often require significantly greater
investment than those centered on a single technology, and may also require
unusually large investments in capital equipment. However, applications
exceeding these ceilings without prior approval from the NCRR DBT Director
will be returned without review.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
Eligibility for Biomedical Technology Resource Center Grants is limited to
those institutions located in the United States. Both profit and nonprofit
organizations are eligible for support. Foreign institutions may be included
as subcontracts.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are encouraged to
apply for NIH grants.
SPECIAL REQUIREMENTS
Applicants are encouraged to contact NCRR Program staff well in advance of
the application submission date, in order to discuss the proposed research
program, budget, organization of the resource, and its potential biomedical
impact. These contacts help to assure that applicants have a clear
understanding of current Program policies and priorities, especially with
respect to any special situations, such as the inclusion of consortia,
subcontracts, etc. It will also allow staff to assess responsiveness to this
PA, provide appropriate guidance as needed, and provide necessary clearances
to exceed budget ceilings delineated in this announcement. Applications
should conform to the requirements of this PA and the BT Resource Center
guidelines, found at (http://www.ncrr.nih.gov/biotech/btguide2.pdf).
Biomedical Technology Research Resource centers have a five-fold mission of
technology R&D, collaborative research, service, training, and dissemination.
They represent a critical mass of both technological and intellectual
resources assembled with the intent of exploiting advances in instrumentation
and physical methods for biomedical research. These resources create
critical, often unique technology and methods at the forefront of their
respective fields that are applicable to a wide variety of problems in the
biological sciences. This is accomplished through a synergistic interaction
of technical and biological expertise, both within the resources and through
intensive collaborations with other laboratories. At their best, these
resources should be in an optimal position to: identify unexpected
opportunities for technological advances to open new lines of biological
inquiry, and appreciate which problems they may be in a position to solve by
creation of new tools. This intense synergy between technology development
and biological problem-solving gives the resources a fundamentally different
character from that of labs engaged in investigator-initiated or other
center-related projects with more narrowly defined goals.
A properly constituted research resource constantly strives to provide
service and training to outside investigators, and to disseminate the
technology and methods it has developed. These efforts require a
fundamentally outward-looking philosophy. The goal of these efforts is to,
so far as is possible, achieve a broader impact on biomedical research than
would be possible through the projects in which the resource can participate
directly. Ultimately, this process should drive toward the widespread and
routine application of the technologies being actively disseminated.
Technological Research and Development:
Technological R&D is most effective when it responds to emerging needs of the
biomedical research community. However, the Resource Center technology must
be dynamically evolving and an important area for R&D in its own right. The
technological R&D or core component consists of investigations that are at
the cutting edge of the technological field with a goal of increasing its
usefulness in biomedical research. A minimum of three technological research
projects constitutes the core section of the resource grant application. For
example, these projects may involve development of new or significant
modification of existing instruments or methods, development of new computer
algorithms and related software or new methods to prepare samples for
instrumental analysis, or development of innovative applications through the
integration of existing technologies. An element of high risk (and
potentially high payoff) may be present in one or more of the core projects
and is appropriate for this component. Investigators should, however, present
alternative approaches to solving technological problems in the event that
their main conceptual thrust should prove unfeasible.
The technological R&D projects to be conducted must be presented in detail.
For each project describe the background, objectives, rationale, methods and
procedures, significance, and facilities available to conduct the project. If
research activities involve support at more than one location through a
consortium/contractual arrangement, the application should provide a separate
description, detailed budget and budget justification for the
consortium/contractual component(s).
The development of individual technologies and methods should be described in
detail. In addition, the interrelationships of these technologies should be
described, as well as plans for maximizing connectivity and synergy both in
the technologies and between participating groups. These discussions should
be placed in the context of the overall strategic goals of the center"s
research program.
Collaborative Research:
In concert with investigators from other institutions, Resource Center staff
should continuously develop new, significant applications of the resource
technology in the biomedical sciences. This is best accomplished through
high-quality collaborative research projects that are closely related to core
technology development. These projects involve experts in the technology,
usually resource personnel, working jointly with investigators outside the
resource who have expertise in a particular biomedical discipline. Such
efforts should lead to joint publications and, in some cases, patents. The
collaborations should drive the technological R&D and the technology should
significantly advance the frontiers of the collaborative research projects.
In an integrated center for proteomics or glycomics, a particular biological
system or problem may be adopted by the project team as a major research
focus, in order to provide a framework for development of analytical
technologies and strategies. If this is the case, this biological focus may
be presented as a major collaboration, and may in fact dominate the initial
activities of the resource. However, over time, it is expected that the
resource will adopt an increasingly outward focus on a broad range of
challenging biological problems that will provide both new drivers and new
opportunities for technology research and development.
Collaborative projects enable non-core researchers to interact with the
Resource staff to pursue areas of common interest that further the Resource"s
research objectives. These projects are selected for the impact they will
make on the technological field as well as for advancing the frontiers of
biology and medicine. For each collaborative project, describe the specific
objectives: the rationale for the proposed approach to the problem, methods,
and procedures to be used, the significance of the proposed work, and the
impact of the expertise of the Center"s core staff along with the technology
developed at the Center on the collaborative project. Provide literature
citations. The collaborator"s name, institution and funding status of the
project including principal investigator, grant number, and project period
dates, and also the source of funds should accompany the description of the
project. Collaborative projects that have already been peer-reviewed will be
evaluated on how they clearly advance and stimulate technological resource
development as well as advancing the frontiers of biomedical science. Those
that have not been peer-reviewed should include more detail and will be
evaluated for scientific merit of the research proposed. New applications
should have at least four relevant collaborative projects, three of which are
with investigators outside the Resource Center"s host institution.
Service:
Providing biomedical investigators access to a Resource"s technology
constitutes the service activity. This includes making available specialized
instrumentation, equipment, software and techniques, and offering
consultation and technical assistance in their use. The Resource Center is
expected to be acknowledged in papers resulting from all projects, including
service research projects. While service is one of the key elements of the
Resource, the P41 mechanism is not intended to support centers that are
predominantly service oriented. It is presumed that laboratories that
propose the development of technologies and analytical strategies in new
applications will not be in a position to provide significant access to the
broader research community until the technology has actually been developed
to some degree. This may be particularly true in the case of integrated
centers for proteomics, which may be inwardly focused initially. However, it
is expected that these centers will make every effort to provide access to
new technologies at the earliest practical time in their development.
A representative sample of (no more than 20) research projects to be served
by the resource must be submitted. Each project should be described in
sufficient detail to allow the reviewers to evaluate the need for the
resource technology in the proposed project. The user"s name and institution
and funding status of the project (including principal investigator, grant
number, funding source, and term) should accompany the description of the
project.
Training:
Plans for training activities must be submitted. Examples of appropriate
training activities include: special training on resource facilities to
collaborators and service users of the resource on an individual basis,
routine training and education on the technology or methodology through
hands-on laboratory experience, seminars and lectures on a regular basis,
short courses, symposia and workshops on appropriate topics that bring
together researchers in multidisciplinary areas from academic institutions,
hospitals and industry for discussions on the use of the resource"s
technology in biomedical research. Training can be offered periodically,
often in conjunction with meetings that the user community is likely to
attend. Funds to support courses given for credit may not be requested.
Individuals involved in the training experiences may not be paid a stipend
nor may the training experience be a requirement for receipt of an academic
degree.
Dissemination:
Plans for dissemination of the Resource"s technology, expertise or
accomplishments must be submitted. Appropriate dissemination activities
involve informing the scientific community about the Resource"s technology or
accomplishments by: publishing articles, books, patents, newsletters, annual
reports, special issues of technical journals, web pages, and press releases,
presenting research results at meetings, conducting conferences, distributing
software products, and transferring technologies to industry where they will
be distributed widely. In resources that are developing software, emphasis
should be placed on producing portable, well-documented, user-friendly
software, making it readily available to the user community and providing
user support. All dissemination activities must acknowledge NCRR grant
support.
Management and Organization
A principle underlying this program is that substantial benefits in
technology development and biological problem solving will accrue through
successful integration of the biological, analytical, and informatics domains
of the center. The application should articulate a specific organizational
plan. This plan should describe anticipated interactions between key
personnel in support of the overarching goals of the resource. It should
also maximize synergy between the component technologies. Ultimately, a
successful resource will function as a coherent whole, rather than a
collection of individual technological capabilities. A separate section on
resource organizational structure should address the following:
Organizational Structure: Describe the organizational structure of the
Resource. Indicate how the Resource will relate to the administrative
structure of the grantee institution.
Resource Staff Responsibilities: Describe how the principal investigator and
the proposed resource staff will be organized with respect to the resource
activities: technological R&D, collaborative research, provision of service,
training, dissemination and general resource administration. Describe the
scientific and technical expertise of the staff that will operate, maintain,
and develop the Resource capabilities.
Resource Operating Procedure: Describe operating procedures and policies
planned for the Resource. Also describe methods for selecting collaborative
research and service projects, and the instructions on how they are to
acknowledge support provided by the Resource in any resulting publications.
Resource Advisory Committee: The advisory committee is appointed by the
principal investigator (PI) and advises the P.I. on future directions for the
Resource particularly in planning additional grant applications and in
setting priorities for allocation of Resource facilities. The committee chair
should be knowledgeable about the Resource"s technology and the science it
serves, but should not be a member of the Resource staff or a major user of
the resource. Other committee membership should be balanced among scientists
knowledgeable about the Resource"s technology, experts in its application to
biomedical research problems and users of the technology. Committee members
should be from the geographical regions served and membership should be
rotated periodically. The committee chair and a majority of members should be
from outside the host institution. The advisory committee should meet at
least annually at the Resource Center and prepare a written report of its
recommendations. This report must be supplied as part of the Resource"s
annual progress report and must be available for NIH staff review during site
visits.
Describe the role of the resource advisory committee. For example, explain
the committee"s role in advising on instrument purchases, reviewing
collaborative and service projects for merit and appropriateness, and
allocating instrument time. The scientific disciplines to be represented by
the advisory committee should be provided. Names of committee members should
also be included, if already appointed, accompanied by a brief description of
their qualifications. An executive committee, perhaps a local subcommittee of
the advisory committee, may be included as an adjunct to the full advisory
committee as well as a medical committee if there is substantial involvement
of human subjects in research projects. Funds may be requested in the
consultant category of the budget to support the costs related to a resource
advisory committee.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your questions about scientific/research issues to:
Douglas M. Sheeley, Sc.D.
Division of Biomedical Technology
National Center for Research Resources
6705 Rockledge Drive, MSC7965
Bethesda, MD 20892-7965
Telephone: (301) 435-0755
FAX: (301) 480-3659
Email: sheeleyd@ncrr.nih.gov
o Direct your questions about peer review issues to:
Noni Byrnes, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, MSC7806
Bethesda, MD 20892
Telephone: (301) 435-1217
FAX: (301) 435-2327
Email: byrnesn@csr.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Mary Niemiec
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, MSC7965
Bethesda, MD 20892-7965
Telephone: (301) 435-0842
FAX: (301) 480-3777
Email: maryn@ncrr.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this PA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIH staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the appropriate date listed at the
beginning of this document. The letter of intent should be sent to:
Douglas M. Sheeley, Sc.D.
Division of Biomedical Technology
National Center for Research Resources
6705 Rockledge Drive, MSC7965
Bethesda, MD 20892-7965
Telephone: (301) 435-0755
FAX: (301) 480-3659
Email: sheeleyd@ncrr.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
Required information, in addition to that requested in the Form PHS 398
instructions, is listed below, by section. Neither a site visit nor an
applicant interview is guaranteed as part of the review of the resource grant
application. The written application should be complete and stand on its own.
The application should be written with the expectation that no site visit or
interview will occur.
Form Pages 4-5: The budget should be completed as described in the
instruction sheet for Application for a Public Health Service Grant (Form PHS
398). Funds may be requested for technological R&D, training, dissemination,
advisory committee meetings (in the consultant costs) and the Resource"s
expenses associated with collaborative and service projects. Graduate student
and postdoctoral support can be requested only if they are active
participants in a core research project. The level of the requested budget
should be clearly supported by the research plan. The outside investigators
of collaborative and service projects must derive support for their projects
from sources outside the Resource Center.
The budget justification beginning on PHS Form Page 5 should include a
detailed justification for key personnel. The percentage effort for each of
the staff on research should be specified for a) each of the core projects,
b) collaboration, and c) service in the budget justification.
A detailed justification should also be supplied for the equipment requested
for the Resource. Appropriate price quotes should be included for major items
of equipment costing more than $25,000. An evaluation of alternative
instruments or manufacturers should be included along with a discussion of
the proposed procurement plan. Similar justifications should be provided for
any subcontractual or consortium arrangements. Use continuation pages as
needed.
Section 6, Biographical Sketches should be included for key personnel for
whom salary support is requested in the application and for each of the
principal collaborators.
Section 9, Research Plan, A-D: The page limitation specified in the PHS 398
for items A-D of the Research Plan does not apply, but applicants are
reminded to be succinct as well as complete. The length of the application
should be consistent with the scope of the proposed research and the number
of collaborative and service projects. It is important to be concise, but
there should be sufficient information about each core, collaborative, and
service project to permit its evaluation.
Section 9, Research Plan C: Preliminary Studies/Progress Report should
include a plan that states long-term goals and overall objectives for the
resource and a projected timetable for technology development. Information on
factors and events contributing to the decision to create the resource and on
comparable resources elsewhere should be presented. Applicants should explain
in detail what makes this particular resource "unique" in terms of its
intellectual and technological capabilities. For supplemental applications, a
brief summary of the Resource Center"s progress should be included. Include
copies of the Resource Center"s most recent annual progress report and
minutes of the most recent Advisory Committee meeting in the Appendix.
Section 9, Research Plan D: Research Design and Methods should include a
discussion of the proposed research in each of the three major resource
activities: technological R&D, collaborative research, and service. Indicate
the relative emphasis to be given to these activities and explain the
proposed division of effort. Plans for training and dissemination should also
be presented.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit. All new,
competing renewal, and supplemental P41 applications are due on the February
1, June 1, and October 1 dates.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
Contact the NCRR program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study:
2) Obtain agreement from the NCRR staff that the NCRR will accept your
application for consideration for award, and,
3) Identify, in a cover letter sent with the application, the staff member
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate advisory council
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application"s overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below)
DATA SHARING: The NIH encourages the timely dissemination of research tools
and results, in support of further research and development. The NIH has
issued a document that addresses these concerns
(http://www.ott.nih.gov/policy/rt_guide_final.html).
Dissemination of the technologies and methods which are developed, as well as
appropriate training for colleagues, are critical components of Biomedical
Technology Research Resources. Specific plans for dissemination of tools
developed as well as scientific results should be an integral part of any
application. The increasing size and complexity of proteomic data sets
presents challenges with respect to data sharing. In addition, it is
possible that extensive and potentially very valuable databases may be
developed by these centers in the course of their work. The disposition of
these data, accessibility, and curation, particularly vis-à-vis existing or
parallel data repositories should be addressed.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
OTHER REVIEW CRITERIA:
P41-supported research resources serve a unique purpose in the broad context
of NIH-funded research. This specialized role requires a distinct set of
qualities that can be defined largely in terms of their resulting impact on
the biomedical sciences. In addition to the fundamental NIH-wide criteria
described above, these resource center applications are reviewed according to
criteria that focus on the quality of the five component activities of the
proposed center, as well as its potential for broad biomedical impact.
Review guidelines can be found at
http://www.ncrr.nih.gov/biotech/p41revguidelines07082002.pdf. It is
recommended that applicants familiarize themselves with that material as they
prepare their proposals. As indicated above, the proposal should be prepared
with the presumption that there will be no site visit or interview. The
proposal should stand on its own.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.371, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.